Material supplier

In the 510(k) change guidance, a new supplier is looked at through what it supplies. The question is whether the material itself changes in formulation or properties, which the manufacturer confirms through its purchasing controls and incoming checks.

The firm supplying the raw material to a finished device manufacturer.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology